The invention described herein relates generally to an anchoring member with trailing sutures and a method and device for applying and adjusting those structures to support a bodily structure of a patient, such as a female. The method and device are particularly disclosed in reference to a device and a method for suspending, stabilizing, and/or slightly compressing the female urethra, particularly the urethrovesical junction, thereby improving or maintaining urinary continence in a female patient without a need for percutaneous incision.
Female incontinence, the inability to control the outflow of urine in women, can have a variety of causes. In roughly a third of the women afflicted, urinary incontinence is the result of intrinsic sphincter deficiency (ISD) wherein the urethral sphincter does not coapt properly. In approximately a second third of the women experiencing urinary incontinence, it is the result of hypermobility wherein the muscles and lateral attachments adjacent to the bladder neck relax such that the bladder neck and proximal urethra tend to rotate and descend in response to intra-abdominal pressure.
Hypermobility can be the result of pregnancy or the ensuing childbirth or from other factors that tend to weaken the relevant muscles. In still further cases, urinary incontinence in women results from the combined effects of ISD and hypermobility. Even further still, a number of other conditions can contribute to urinary incontinence in women. For example, congenital defects, disease, injury, aging, and urinary tract infection can all lead to urinary incontinence. As one will appreciate, women suffering from incontinence unfortunately experience an involuntary escape of urine, particularly during coughing, sneezing, and other actions that produce an increase in intra-abdominal pressure.
Advantageously, it has been discovered that female stress incontinence can be corrected by surgical restoration of the urethrovesical junction to its proper orthotopic position. Stated alternatively, female urinary incontinence can be remedied by suspending, stabilizing, and/or compressing the bladder neck to achieve a position wherein incontinence will be avoided but normal urinary function will not be hindered. For the remedial procedure to be successful, the position of the bladder neck must be high enough to avoid incontinence even when under stress while not being so high that proper bladder voiding is prevented.
The prior art discloses a plurality of methods and devices for carrying out urethrovesical suspension procedures. For example, female urinary stress incontinence has been treated surgically by effectively tying the urethrovesical junction to the back of the symphysis pubis. Beginning at least as early as 1913 and extending to the present, a number of skilled inventors including Kelly, Lemay, Pereyra et al., Burch, Stamey, Mueller et al., and Cobb et al. together have defined the present state of the art and have helped to refine particularized apparatuses and techniques in the hope of yielding improved results.
For example, four relatively non-invasive surgical procedures for bladder neck suspension are described in Hadley et al., Urologic Clinics of North America, Vol. 12, No. 2, p. 291 (1985). In the original Pereyra method, a needle is passed from a suprapubic incision to an incision in the vagina near the bladder neck. Suture material is passed several times from the bladder neck to the suprapubic incision to suspend the bladder neck. The Cobb-Radge method inserts the needle from below through the vaginal incision. The Stamey procedure uses an endoscope to prevent the surgical needle from puncturing the bladder, and a Dacron vascular graft is used to anchor a nylon suture in the periurethral tissue. Under the Raz method, the surgeon inserts his or her finger through the vaginal incision to guide the suspension needle and avoid penetration of the bladder by the needle. The sutures are anchored by threading through tissue of the vaginal wall and tissue in the suprapubic area.
Unfortunately, many prior art techniques have involved cutaneous incisions and have commonly required that the patient be subjected to a general anesthesia. Furthermore, many such procedures are not conveniently subject to repeat applications notwithstanding the unfortunate reality that second and further operations can be necessary in many cases. Still further, a number of these procedures have been found to cause urethral distortion. Even further still, procedures involving suturing the urethral lumen directly to the symphysis pubis and placing additional sutures through the bladder have been found to result in urine loss and, possibly, the formation of bladder stones. Additionally, these relatively invasive methods can lead to other complications including enteropecele (a hernia within the vaginal wall) and genital prolapse, a descending of the uterus as a result of a weakness in the pelvic floor. Yet further, women undergoing such procedures can require six weeks or more before their preoperative lifestyle can be resumed.
In a relative advance in the art, U.S. Pat. No. 5,013,292 to Lemay discloses a method and kit for correcting female urinary incontinence wherein only a local anesthesia is required. The Lemay patent calls for the implantation of a head portion of an implant in the skin above the symphysis pubis. Ultimately, the head portion rests on the symphysis pubis with two dangling ends of a suture portion extending therefrom to allow an adjustment the urethrovesical angle. Unfortunately, as detailed below, even this improved Lemay device and procedure are quite complex and require a number of incisions to be made in a patient""s abdominal skin. Not only do such incisions add to the discomfort associated with the procedure, but they also increase the risk of infection, dehiscence, and osseous complications.
Stated most basically, the Lemay procedure begins with the cutting of an approximately 1 cm incision in the vaginal mucosa at the urethrovesical junction, which is followed by the insertion of a hollow needle or cannula through the incision, through the space of the retzius, and outwardly through the patient""s skin at a point where a 0.5 cm cutaneous incision is then made. A trocar is then removed from the need, and, while the cannula is still in place, one end of one suture of a first implant is slid through the cannula until the suture protrudes through the vagina. The needle is then removed, and, with the trocar again attached, the needle is reinserted at a different point in the vaginal incision until it passes through the cutaneous incision. The trocar is then removed, and the second end of the suture of the first implant is passed through the cannula to the vagina. Essentially the same procedure is performed relative to the second implant at a slightly displaced location. Then, the implants are buried under the skin overeat symphysis pubis, the urethrovesical angle is adjusted to a desired position, and the ends of the sutures are tied to act as a support to suspend, compress, and/or stabilize the urethrovesical junction at a desired angle.
U.S. Pat. No. 4,705,040 to Mueller et al., entitled Percutaneous Fixation of Hollow Organs, describes another method and device for supporting, compressing, and/or stabilizing a hollow body organ. Under the Mueller et al. method, a hollow needle carrying a T-shaped head with a trailing filament is driven through a patient""s skin. The T-shaped head is then released from the needle, and the organ is fixed in a supported, compress, and/or stabilized position by an adjusting of the tension in the filament and a clamping of the filament outside the patient""s body. Disadvantageously, the Mueller et al. method and device also requires for its installation that an incision be made in the patient""s skin.
In light of the present state of the art as outlined above, a number of observations can be made. Most basically, it is clear that a number of proficient inventors have cooperated, both through individual and in collaborative efforts, to provide a progression of improved methods and devices for supporting, compressing, and/or stabilizing organs and, more particularly, for confronting female incontinence. It is also clear, however, that even those devices and procedures presently considered simplified and minimally invasive require rather complex surgical procedures and devices and call for the cutting of a number of incisions in a patient""s skin and elsewhere. With this, even these improved methods and devices leave a patient at risk of infection, dehiscence, osseous, and still other complications.
Consequently, one considering the present state of the art will appreciate that there remains a need for a method and device for correcting female incontinence that eliminates the need for skin incisions, that is simple in construction and use, and that thereby remedies the numerous deficiencies left by the prior art.
Advantageously, the present invention is founded on the most basic object of providing an anchoring member with at least one trailing suture and a method and device for applying and adjusting those structures to support a bodily element of a patient, such as the urethrovesical junction in a female patient.
In particular embodiments, the invention provides a method and device for correcting incontinence, particularly female incontinence, that solves the problems that have hindered the prior art while demonstrating a plurality of further advantages thereover.
A fundamental object of the invention is to provide a method and device that can be employed, for example, to correct female incontinence in an effective manner while not hindering normal urinary function.
Another basic object of the invention is to provide such a device and method that does not require cutaneous incisions for its implantation.
A further object of the invention is to provide such a device, which may be employed for correcting female incontinence, that is simple in construction.
Yet another object of the invention is to provide a method, which can be used for correcting female incontinence, that can be carried out relatively simply, conveniently, and with minimal trauma to a patient.
An underlying object of the invention is to provide such a method and device that minimizes the risk of infection, dehiscence, and osseous complications resulting from the procedure.
These and further objects and advantages of the present invention will be readily obvious not only to one skilled in the art who has reviewed the present disclosure but also to patients and physicians who experience an embodiment of the present invention in installation and effect.
In accomplishing the aforementioned objects, a most basic embodiment of the present invention is exemplified by a method for the transvaginal correction of urinary incontinence in females without percutaneous incision. There, the method can begin with the steps of providing a delivery needle that comprises an elongate cannula with a proximal end and a distal end, providing a stylet that comprises an elongate rod for being matingly received into the cannula of the delivery needle, and providing a support, which can be termed a urethrovesical support, that comprises an anchor toggle with at least a first suture that has a proximal end fixed possibly to a central portion thereof.
With these elements provided, the distal end of the elongate cannula of the delivery needle is then inserted partially into the area of the patient""s perineum, such as through the vagina of a female patient""s body that has a bladder structure with a bladder, a urethrovesical junction, and a urethra. With a small incision made in the upper wall of the vagina or perineum and first and second lateral incisions made to opposite sides of, for example, the urethra, the distal end of the cannula is passed through the small incision, through the first or second incision, across the space of the Retzius behind the symphysis pubis, and then to a desired supporting location. Once the distal end of the cannula is in the desired supporting location, the anchor toggle of the urethrovesical support is deployed by sliding the elongate rod of the stylet increasingly deeper into the cannula of the delivery needle until the distal end of the elongate rod drives the anchor toggle out of the distal end of the cannula and into the desired supporting location.
With the anchor toggle so located, the elongate cannula of the delivery needle can be removed from the patient""s body thereby leaving the anchor toggle in position and leaving the at least one elongate first suture in place tracing the path of the cannula of the delivery needle. Finally, the at least one suture can be supportingly coupled to, by way of example, the bladder structure of the patients body thereby providing support to the bladder structure with the anchor toggle acting as a supporting anchor and the at least one suture acting as a supporting line.
With certain embodiments of the present invention for a method and device generally described, relating in this case to a method and device for the transvaginal correction of urinary incontinence in females, one will appreciate that the foregoing discussion broadly outlines the more important features of the invention. As such, the foregoing is designed merely to enable a better understanding of the detailed description that follows and to instill a better appreciation of the inventor""s contribution to the art. Before any particular embodiment of the invention is explained in detail, it must be made clear that the following details of construction, descriptions of geometry, and illustrations of inventive concepts are mere examples of the many possible manifestations of the invention.